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FI3564378T3 - Immunogenic composition - Google Patents

Immunogenic composition Download PDF

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Publication number
FI3564378T3
FI3564378T3 FIEP19179871.9T FI19179871T FI3564378T3 FI 3564378 T3 FI3564378 T3 FI 3564378T3 FI 19179871 T FI19179871 T FI 19179871T FI 3564378 T3 FI3564378 T3 FI 3564378T3
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FI
Finland
Prior art keywords
fragment
repeat
proximal end
polypeptide according
toxin
Prior art date
Application number
FIEP19179871.9T
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Finnish (fi)
Inventor
Cindy Castado
Original Assignee
Glaxosmithkline Biologicals Sa
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Application filed by Glaxosmithkline Biologicals Sa filed Critical Glaxosmithkline Biologicals Sa
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Publication of FI3564378T3 publication Critical patent/FI3564378T3/en

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1267—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-positive bacteria
    • C07K16/1282—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-positive bacteria from Clostridium (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/62—DNA sequences coding for fusion proteins
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/70—Vectors or expression systems specially adapted for E. coli
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/40—Fusion polypeptide containing a tag for immunodetection, or an epitope for immunisation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/55—Fusion polypeptide containing a fusion with a toxin, e.g. diphteria toxin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Zoology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (15)

PATENTTIVAATIMUKSETPATENT CLAIMS 1. Polypeptidi, joka käsittää ensimmäisen fragmentin ja toisen fragmentin, jolloin (1) ensimmäinen fragmentti on Clostridium difficilen toksiini A:n toistuvan domeenin fragmentti; (ii) toinen fragmentti on Clostridium difficilen toksiini B:n toistuvan domeenin fragmentti; (iii) ensimmäisellä fragmentilla on ensimmäinen proksimaalinen pää; (iv) toisella fragmentilla on toinen proksimaalinen pää; ja jolloin ensimmäinen fragmentti ja toinen fragmentti ovat vierekkäin ja jolloin polypeptidi saa aikaan vasta-aineita, jotka neutraloivat toksiini A:ta ja toksiini B:tä, ja jolloin ensimmäinen proksimaalinen pää ei ole toksiini A:n aminohappoissa 1878-1940, 2012-20774, 2146-2208, 2258-2322, 2394-2456, 2507-2569 tai 2598-2660 ja toinen proksimaalinen pää on toksiini B:n aminohappoissa 1834-1926 tai 1927-2057, mutta ei toksiini B:n aminohappoissa 1881-1942 tai 2012-2057.1. A polypeptide comprising a first fragment and a second fragment, wherein (1) the first fragment is a Clostridium difficile toxin A repeat domain fragment; (ii) the second fragment is a fragment of the Clostridium difficile toxin B repeat domain; (iii) the first fragment has a first proximal end; (iv) the second fragment has a second proximal end; and wherein the first fragment and the second fragment are adjacent and wherein the polypeptide elicits antibodies that neutralize toxin A and toxin B, and wherein the first proximal end is not within amino acids 1878-1940, 2012-20774 of toxin A, 2146-2208, 2258-2322, 2394-2456, 2507-2569, or 2598-2660 and the other proximal end is at toxin B amino acids 1834-1926 or 1927-2057, but not at toxin B amino acids 1881-1942 or 2012- 2057. 2. Patenttivaatimuksen 1 mukainen polypeptidi, jolloin polypeptidi saa nisäkäsisännässä aikaan suojaavan immuunivasteen C. difficile -kantoja vastaan.2. The polypeptide according to claim 1, wherein the polypeptide induces a protective immune response against C. difficile strains in the mammalian host. 3. Jonkin patenttivaatimuksista 1-2 mukainen polypeptidi, jolloin ensimmäinen fragmentti ja/tai toinen fragmentti käsittää vähemmän kuin 25 %, 20 2, 18 2 tai 15 % alfa-helikaalista rakennetta. 3. A polypeptide according to one of claims 1-2, wherein the first fragment and/or the second fragment comprises less than 25%, 20 2, 18 2 or 15% of an alpha-helical structure. 4, Jonkin edellä olevista patenttivaatimuksista mukainen polypeptidi, jolloin ensimmäinen fragmentti ja/tai toinen fragmentti käsittää enemmän kuin 25 %, 30 %, 35 %, 38 % tai 40 % beetalevy-rakennetta.4, A polypeptide according to one of the above claims, wherein the first fragment and/or the second fragment comprises more than 25%, 30%, 35%, 38% or 40% beta-sheet structure. 5. Jonkin edellä olevista patenttivaatimuksista mukainen polypeptidi, jolloin ensimmäinen proksimaalinen pää on lyhyen toiston sisällä.5. A polypeptide according to one of the preceding claims, wherein the first proximal end is within a short repeat. 6. Jonkin edellä olevista patenttivaatimuksista mukainen polypeptidi, jolloin toinen proksimaalinen pää on lyhyen toiston sisällä.6. A polypeptide according to one of the preceding claims, wherein the second proximal end is within a short repeat. 7. Jonkin edellä olevista patenttivaatimuksista mukainen polypeptidi, jolloin ensimmäinen proksimaalinen pää ei katkaise lyhyt toisto - pitkä toisto -— lyhyt toisto -toistojaksoa.7. The polypeptide according to one of the preceding claims, wherein the first proximal end does not interrupt the short repeat - long repeat - short repeat - repeat sequence. 8. Jonkin edellä olevista patenttivaatimuksista mukainen polypeptidi, jolloin toinen proksimaalinen pää ei katkaise lyhyt toisto - pitkä toisto - lyhyt toisto -toistojaksoa.8. The polypeptide according to one of the above claims, wherein the second proximal end does not interrupt the short repeat - long repeat - short repeat repeat sequence. 9. Jonkin edellä olevista patenttivaatimuksista mukainen polypeptidi, jolloin ensimmäinen proksimaalinen pää ja toinen proksimaalinen pää eivät katkaise lyhyt toisto - pitkä toisto - lyhyt toisto -toistojaksoja.9. A polypeptide according to one of the preceding claims, wherein the first proximal end and the second proximal end do not interrupt the short repeat - long repeat - short repeat repeat sequences. 10. Jonkin edellä olevista patenttivaatimuksista mukainen polypeptidi, jolloin ensimmäinen proksimaalinen pää on toksiini A:n toistojakson VIII (aminohapot 2645-2710) sisällä, valinnaisesti toksiini A:n aminohappojen 2700-2710 tai 2680-2690 sisällä.10. A polypeptide according to any one of the preceding claims, wherein the first proximal end is within repeat VIII (amino acids 2645-2710) of toxin A, optionally within amino acids 2700-2710 or 2680-2690 of toxin A. 11. Jonkin edellä olevista patenttivaatimuksista mukainen polypeptidi, jolloin toinen proksimaalinen pää on aminohappoissa 1860-1878, 1854-1876, valinnaisesti toksiini B:n aminohappoissa 1960-1970, 1988-1998 tai 1867-1877.11. A polypeptide according to one of the above claims, wherein the other proximal end is in amino acids 1860-1878, 1854-1876, optionally in amino acids 1960-1970, 1988-1998 or 1867-1877 of toxin B. 12. Polynukleotidi, joka koodaa jonkin patenttivaatimuksista 1-11 mukaista polypeptidiä.12. A polynucleotide that encodes a polypeptide according to one of claims 1-11. 13. Immunogeeninen koostumus, joka käsittää jonkin patenttivaatimuksista 1-11 mukaista polypeptidiä ja farmaseuttisesti hyväksyttävää apuainetta.13. An immunogenic composition comprising a polypeptide according to one of claims 1-11 and a pharmaceutically acceptable excipient. 14. Patenttivaatimuksen 13 mukainen immunogeeninen koostumus, joka käsittää lisäksi adjuvantin.14. The immunogenic composition according to claim 13, which further comprises an adjuvant. 15. Jonkin patenttivaatimuksista 13-14 mukainen immunogeeninen koostumus käytettäväksi hoidettaessa tai ehkäistäessä C. difficile -sairautta.15. The immunogenic composition according to one of claims 13-14 for use in treating or preventing C. difficile disease.
FIEP19179871.9T 2011-05-27 2012-05-25 Immunogenic composition FI3564378T3 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161490707P 2011-05-27 2011-05-27
US201161490734P 2011-05-27 2011-05-27
US201161490716P 2011-05-27 2011-05-27

Publications (1)

Publication Number Publication Date
FI3564378T3 true FI3564378T3 (en) 2024-01-18

Family

ID=46168484

Family Applications (1)

Application Number Title Priority Date Filing Date
FIEP19179871.9T FI3564378T3 (en) 2011-05-27 2012-05-25 Immunogenic composition

Country Status (25)

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US (5) US9290565B2 (en)
EP (6) EP3564378B1 (en)
JP (3) JP5952390B2 (en)
KR (1) KR102014502B1 (en)
CN (3) CN103732750A (en)
BR (2) BR112013030395B1 (en)
CA (2) CA2837393A1 (en)
CY (3) CY1118599T1 (en)
DK (4) DK2714910T3 (en)
EA (1) EA030898B1 (en)
ES (4) ES2615737T3 (en)
FI (1) FI3564378T3 (en)
HR (4) HRP20180339T1 (en)
HU (4) HUE030823T2 (en)
IL (1) IL229529B2 (en)
LT (4) LT2714911T (en)
ME (1) ME02600B (en)
MX (1) MX346200B (en)
PL (4) PL3564378T3 (en)
PT (4) PT2714910T (en)
RS (1) RS55605B1 (en)
SG (1) SG195037A1 (en)
SI (4) SI3138916T1 (en)
SM (2) SMT201700110T1 (en)
WO (3) WO2012163810A1 (en)

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EP3167899B1 (en) 2010-09-03 2021-03-24 Valneva Austria GmbH Isolated polypeptide of the toxin a and toxin b proteins of c.difficile and uses thereof
MX391236B (en) 2011-04-22 2025-03-21 Wyeth Llc COMPOSITIONS RELATING TO A MUTANT CLOSTRIDIUM DIFFICILE TOXIN AND METHODS THEREOF.
SG11201402375VA (en) 2011-12-08 2014-10-30 Novartis Ag Clostridium difficile toxin-based vaccine
BR122016023101B1 (en) 2012-10-21 2022-03-22 Pfizer Inc Polypeptide, immunogenic composition comprising it, as well as recombinant cell derived from Clostridium difficile
AU2013354186A1 (en) * 2012-12-05 2014-06-12 Glaxosmithkline Biologicals S.A. Immunogenic composition
CA2910200A1 (en) * 2013-04-22 2014-10-30 Board Of Regents Of The University Of Oklahoma Clostridium difficile vaccine and methods of use
ES2870506T3 (en) 2015-02-19 2021-10-27 Immune Biosolutions Inc Clostridium difficile toxins a and / or b epitope antigen and antibody, and their pharmaceutical uses
EP3810163A1 (en) * 2018-06-19 2021-04-28 GlaxoSmithKline Biologicals SA Immunogenic composition
WO2023020992A1 (en) 2021-08-16 2023-02-23 Glaxosmithkline Biologicals Sa Novel methods
WO2023020994A1 (en) 2021-08-16 2023-02-23 Glaxosmithkline Biologicals Sa Novel methods
WO2023020993A1 (en) 2021-08-16 2023-02-23 Glaxosmithkline Biologicals Sa Novel methods
GB202205833D0 (en) 2022-04-21 2022-06-08 Glaxosmithkline Biologicals Sa Bacteriophage
WO2023232901A1 (en) 2022-06-01 2023-12-07 Valneva Austria Gmbh Clostridium difficile vaccine
WO2024160901A1 (en) 2023-02-02 2024-08-08 Glaxosmithkline Biologicals Sa Immunogenic composition

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Publication number Publication date
BR112013030395B1 (en) 2022-11-01
CY1121936T1 (en) 2020-10-14
EA030898B1 (en) 2018-10-31
DK3564378T3 (en) 2024-01-08
HRP20191291T1 (en) 2019-10-18
DK3138916T3 (en) 2019-08-26
SMT201700110T1 (en) 2017-03-08
HRP20231749T1 (en) 2024-03-15
HUE030823T2 (en) 2017-06-28
EP4296361A2 (en) 2023-12-27
PL2714910T3 (en) 2018-06-29
EP2714910B1 (en) 2018-01-10
HUE044772T2 (en) 2019-11-28
EP3327126A1 (en) 2018-05-30
US20160159867A1 (en) 2016-06-09
EP2714911B1 (en) 2016-11-30
PT3138916T (en) 2019-09-17
EP3564378A1 (en) 2019-11-06
WO2012163817A3 (en) 2013-03-21
HRP20180339T1 (en) 2018-03-23
EP3564378B1 (en) 2023-11-01
PT2714911T (en) 2017-02-06
US20170362309A1 (en) 2017-12-21
DK2714911T3 (en) 2017-02-27
JP2014516532A (en) 2014-07-17
SI2714910T1 (en) 2018-04-30
EP2714911A2 (en) 2014-04-09
DK2714910T3 (en) 2018-02-05
US9409974B2 (en) 2016-08-09
PT2714910T (en) 2018-03-09
PL3138916T3 (en) 2019-11-29
ES2743442T3 (en) 2020-02-19
IL229529A0 (en) 2014-01-30
JP5952390B2 (en) 2016-07-13
WO2012163811A1 (en) 2012-12-06
US20170247421A1 (en) 2017-08-31
CN107098977A (en) 2017-08-29
BR112013030396A2 (en) 2016-12-13
MX346200B (en) 2017-03-10
SI2714911T1 (en) 2017-03-31
LT3138916T (en) 2019-08-26
SG195037A1 (en) 2013-12-30
BR112013030395A2 (en) 2016-12-13
LT2714910T (en) 2018-03-12
SI3564378T1 (en) 2024-02-29
LT3564378T (en) 2024-01-25
JP2017012160A (en) 2017-01-19
ES2968455T3 (en) 2024-05-09
HRP20170094T1 (en) 2017-03-24
DK3564378T5 (en) 2024-09-02
ES2660468T3 (en) 2018-03-22
HUE064492T2 (en) 2024-03-28
CY1119916T1 (en) 2018-06-27
EP4296361A3 (en) 2024-02-28
CN103717742B (en) 2018-05-22
CN103717742A (en) 2014-04-09
EA201391548A1 (en) 2014-06-30
EP3138916A1 (en) 2017-03-08
WO2012163817A2 (en) 2012-12-06
ES2615737T3 (en) 2017-06-08
IL229529B2 (en) 2023-05-01
MX2013013924A (en) 2013-12-16
RS55605B1 (en) 2017-06-30
US20140093529A1 (en) 2014-04-03
ME02600B (en) 2017-06-20
IL229529B1 (en) 2023-01-01
PT3564378T (en) 2024-01-26
CA2837395A1 (en) 2012-12-06
CY1118599T1 (en) 2017-07-12
EP2714910A1 (en) 2014-04-09
SMT201700110B (en) 2017-03-08
CA2837393A1 (en) 2012-12-06
KR102014502B1 (en) 2019-08-26
US10093722B2 (en) 2018-10-09
WO2012163810A1 (en) 2012-12-06
EP3138916B1 (en) 2019-06-19
KR20140019848A (en) 2014-02-17
PL2714911T3 (en) 2017-05-31
HUE037126T2 (en) 2018-08-28
SI3138916T1 (en) 2019-08-30
US9644024B2 (en) 2017-05-09
US10377816B2 (en) 2019-08-13
US9290565B2 (en) 2016-03-22
US20140178424A1 (en) 2014-06-26
LT2714911T (en) 2017-02-10
CN103732750A (en) 2014-04-16
JP2014522238A (en) 2014-09-04
CA2837395C (en) 2021-05-18
PL3564378T3 (en) 2024-03-11

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